HC Deb 01 April 1996 vol 275 cc53-4W
Mr. Simon Hughes

To ask the Secretary of State for Health if he will list for the calendar year 1995, for each member of the Committee on Safety of Medicines, the number of meetings at which they were present and the number of meetings from which they were absent. [22085]

Mr. Malone

I refer the hon. Member to the reply I gave him on 28 March,Official Report, column 748.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer of 11 December 1995,Official Report, columns 520-–21, what steps he took to establish that no member of the Committee on Safety of Medicines received the papers dispatched on 11 October after 10.30 am on 12 October 1995. [22086]

Mr. Malone

Delivery times are guaranteed by the courier service used. No member complained that the papers were not received on time.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answers of 11 December 1995,Official Report, column 521, and 14 December 1995, Official Report, column 811, on what basis expenditure on travel and subsistence during the period 1990 to 1995 was made; and if the expenditure was approved by the National Audit Office. [22088]

Mr. Malone

The expenditure on travel and subsistence was incurred in the performance of the normal duties of the committees.

The expenditure referred to in the reply I gave the hon. Member on 11 December 1995, columns 521–22, has been included in the accounts of the Medicines Control Agency, which since 1 April 1992 have been subject to audit by the National Audit Office.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer of 11 December 1995,Official Report, column 523, what limitations section 4(2) of the Medicines Act 1968 imposes on the scope of activity and advice of committees, set up under section 4 of the Act. [22089]

Mr. Malone

Section 4(2) of the Medicines Act 1968 provides that committees may be established under section 4(1) of that Act for any purpose, or combination of purposes, connected with the execution of that Act or the exercise of any power conferred by it, either generally or in relation to any particular class of substances or articles to which any provision of that Act is applicable. The implication is that such committees cannot be established for other purposes and that their activities and advice may not relate to other purposes.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer of 14 December 1995,Official Report, column 811, to the hon. Member for Gordon Mr. Bruce), what factors justify the appointment of members of the Committees on Safety of Medicines or other section 4 committees for a period in excess of the prescribed maximum of six years.[22090]

Mr. Malone

Members are normally appointed for a three-year period and may be reappointed for further terms of office. Members are appointed and reappointed for their individual expertise in the fields of medicine, pharmacy or science. Their specialist knowledge and judgment contribute to the advice given by the committee to the Licensing Authority.

Mr. Hughes

To ask the Secretary of State for Health, pursuant to his answer of 14 December 1995,Official Report, column 810, to the hon. Member for Gordon (Mr. Bruce), what quality assurance proceedings relating to pharmacovigilance are in place in the Medicines Control Agency. [22091]

Mr. Malone

The Medicines Control Agency's performance in pharmacovigilance is measured against a number of high-level targets, set to protect pubic health in the field of medical products. These are published in the agency's business plan and its accomplishments against them in its annual report, copies of which are available in the Library. The agency has in place a large number of rigorous standard operating procedures relating to its many pharmacovigilance functions in order to ensure that good pharmacovigilance practice is carried out. Assessment reports on important safety issues relating to licensed medicines are subject to peer review both with the agency and by independent experts on the relevant advisory committees.

All agency procedures are subject to audit by the National Audit Office and internal Department of Health auditors.